Comparative Effect of Theipoental and Propofol in IVF Outcome
1 other identifier
interventional
180
1 country
1
Brief Summary
In this study the aim is to compare the effect of the type of anaesthetic drug used during oocyte retrieval on fertilization rates of oocytes retrieved after ovarian stimulation for in-vitro fertilization.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2009
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 25, 2015
CompletedFirst Posted
Study publicly available on registry
March 4, 2015
CompletedMarch 4, 2015
February 1, 2015
4.2 years
February 25, 2015
March 3, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Fertilization rate
The number of oocytes fertilized divided by the number of oocytes in which fertilization was attempted per randomized patient
First 24h after oocyte retrieval
Secondary Outcomes (4)
Number of MII oocytes
12h after oocyte rertieval
Pregnancy rate
14 days after embryo transfer
Implantation rate
40 days after embryo traansfer
The concentration of propofol or thiopental in the follicular fluid of the dominant (larger) follicle aspirated at oocyte retrieval
12 hours after oocyte retrieval
Study Arms (2)
Propofol
EXPERIMENTALIn this arm patients will be receiving propofol for anaesthesia at doses 3-5mg depending on the time needed to complete oocyte retrieval
Thiopental
ACTIVE COMPARATORIn this arm patients will receive thiopental for anaesthesia at doses 7mg and a repeat dose of 2-3mg depending on the time needed to completed oocyte retrieval
Interventions
Propofol intravenous infusion for introduction and maintance of anaesthesia at doses 3-5mg depending on the total time needed for completion of oocyte retrieval
Patients will receive thiopental in addition to fentanyl for introduction and maintanance of anaesthesia at doses 7mg. IF required patients will receive a repeat dose of 1-3mg of thiopental depending on the totla time needed to complete oocyte retrieval
Eligibility Criteria
You may qualify if:
- women undergoing oocyte retrieval for IVF under general anesthesia
- age ≤45 years
You may not qualify if:
- women with a known hypersensitivity to the active substance of the investigating drugs or any of their excipients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unit for Human Reproduction, 1st Dept of OB/Gyn, Medical School, Aristotle UNiversity of Thessaloniki
Thessaloniki, Thessaloniki, 54603, Greece
Related Publications (1)
Goutziomitrou E, Venetis CA, Kolibianakis EM, Bosdou JK, Parlapani A, Grimbizis G, Tarlatzis BC. Propofol versus thiopental sodium as anaesthetic agents for oocyte retrieval: a randomized controlled trial. Reprod Biomed Online. 2015 Dec;31(6):752-9. doi: 10.1016/j.rbmo.2015.08.013. Epub 2015 Sep 4.
PMID: 26515147DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 25, 2015
First Posted
March 4, 2015
Study Start
January 1, 2009
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
March 4, 2015
Record last verified: 2015-02